510k
Database
Specialties
Anesthesiology
484
Cardiovascular
1476
Chemistry
340
Dental
1160
Ear, Nose, Throat
216
Gastroenterology & Urology
852
General & Plastic Surgery
1930
General Hospital
1468
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
834
Obstetrics & Gynecology
368
Ophthalmic
249
Orthopedic
2539
Pathology
49
Physical Medicine
452
Radiology
2088
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
285
GEI
Electrosurgical, Cutting &...
267
QIH
Automated Radiological Image...
258
HRS
Plate, Fixation, Bone
249
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
208
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
175
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Harbor Medical Devices, Inc.
Medical Device Manufacturer
·
US , Boston , MA
Harbor Medical Devices, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1988
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Harbor Medical Devices, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
May 15, 1989
HARBORIN CENTRAL VENOUS CATHETER
K884628
·
DQR
Cardiovascular
·
189d
Cleared
Dec 13, 1988
HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT
K882657
·
DYB
Cardiovascular
·
167d
Cleared
Jul 28, 1988
HARBOR CENTRAL VENOUS CATHETER
K881884
·
DQR
Cardiovascular
·
85d
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7
General Hospital
4
Cardiovascular
3